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    Quality & RiskQuality System

    Quality Manual

    Top-level QMS document describing scope, processes, and their interactions.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    ISO 13485 §4.2.2 requires a Quality Manual that documents QMS scope, justifications for any exclusions, references to documented procedures, and a description of process interactions.

    What this means in practice

    Often the first document an auditor opens; clarity and accuracy here set the tone for the rest of the audit.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·2FDA·1
    1. 1
      ISO 13485:2016
      Verified
      ISOiso.org
    2. 2
      FDA - Quality Systems
      Verified
      FDAfda.gov
    3. 3
      ISO 13485 Standard Page
      Verified
      ISOiso.org

    Inline markers like [1] jump to the matching reference above.